Pregnancy Safety Of Winlevi

Winlevi (clascoterone) is a prescription cream used to treat acne in people aged 12 and older. It is not known if Winlevi is safe for use during pregnancy. Animal studies have shown that the medication may cause birth defects, but there are no controlled data in human pregnancy. As a result, the potential risks and benefits should be discussed with a healthcare provider.

Winlevi is not recommended during pregnancy

Winlevi is a prescription medication for acne vulgaris treatment. It contains clascoterone, an androgen receptor inhibitor. While it is deemed safe for people aged 12 and above, it is not recommended for use during pregnancy.

Before using Winlevi, it is important to inform your healthcare provider if you are pregnant or planning to become pregnant. Although there are no controlled data in human pregnancy, animal studies have shown that this medication can cause birth defects. It is categorised as a US FDA pregnancy category "Not Assigned", indicating that there are no data on the developmental risks associated with its use during pregnancy. The animal data suggests that the drug may cause fetal harm. Therefore, it is recommended to discuss the risks and benefits with your doctor if you are considering using Winlevi during pregnancy.

Additionally, it is unknown if Winlevi passes into breast milk. There are no data on the effects of the drug on breastfed infants or its impact on milk production. As a result, it is advised to consult your doctor about the best way to feed your baby during treatment with Winlevi.

Winlevi is a relatively new medication, having been approved by the FDA in 2020. The lack of long-term data on its use during pregnancy and breastfeeding means that there may be unknown risks associated with its use during this time. Therefore, it is recommended to err on the side of caution and avoid using Winlevi during pregnancy unless clearly needed and advised by a doctor.

In conclusion, while Winlevi is a safe and effective treatment for acne in individuals aged 12 and above, it is not recommended for use during pregnancy due to potential risks to the fetus. It is important to consult with a healthcare provider and discuss the benefits and risks before using Winlevi if you are pregnant or planning to become pregnant.

Animal studies show it may cause birth defects

Winlevi (clascoterone) is a topical cream used to treat acne in people aged 12 and older. It is not known if Winlevi is safe for children under 12. It is also not known if Winlevi cream will harm an unborn baby. However, animal studies have shown that this medication can cause birth defects.

Animal reproduction studies have shown evidence of increased malformations and post-implantation loss and resorptions after subcutaneous administration at exposures greater than those used clinically. There are no controlled data in human pregnancy. The US FDA has not assigned a pregnancy category to Winlevi, and the pregnancy labeling rule has been amended to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help healthcare providers make prescribing decisions and counsel women about the use of drugs during pregnancy.

The active ingredient in Winlevi, clascoterone, is also known as cortexolone 17α-propionate. It works by blocking androgen receptors in the sebaceous glands and hair follicles of the skin, reducing oil (sebum) production and inflammation, which improves acne. It is the only acne medication thought to work by blocking hormones that can cause acne.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of using Winlevi with your healthcare provider.

It is not known if Winlevi passes into breast milk

Winlevi is a prescription medication for acne vulgaris treatment. It contains clascoterone, an androgen receptor inhibitor. It is not known if Winlevi is safe and effective for children under 12 years of age.

There are a few important things to consider regarding pregnancy and breastfeeding when using Winlevi. Firstly, it is not known if Winlevi will harm an unborn baby. Animal studies have shown that the medication can cause birth defects, but there are no controlled data in human pregnancy. Therefore, it is recommended to discuss the risks and benefits with a healthcare provider if pregnant or planning to become pregnant.

Secondly, it is not known if Winlevi passes into breast milk. There are no data on the effects of the drug on the breastfed infant or its impact on milk production. Again, it is advised to consult a healthcare provider about the best way to feed a baby while undergoing treatment with Winlevi.

To ensure the safe use of Winlevi, it is important to follow the instructions provided by a healthcare provider. It is also crucial to inform the provider about any medical conditions, allergies, and other medications being taken. This information will help assess the risks and benefits of using Winlevi during pregnancy and breastfeeding.

In summary, while Winlevi is a prescription medication for acne treatment, it is important to exercise caution during pregnancy and breastfeeding due to the lack of data and potential risks involved. It is always advisable to consult a healthcare provider for personalized advice and to ensure the medication is used safely and effectively.

It is not known if Winlevi will harm an unborn baby

Winlevi (clascoterone) is a prescription medication for acne vulgaris treatment. It is a topical cream that works by blocking androgen receptors in the sebaceous glands and hair follicles of the skin, reducing oil (sebum) production and inflammation, which improves acne. The cream is only for use on the skin and should not be used in or on the eyes, mouth, or vagina.

If you are pregnant or planning to become pregnant, it is important to know that it is not known if Winlevi cream will harm your unborn baby. There have been no controlled data studies in human pregnancy. Animal reproduction studies have shown evidence of increased malformations and post-implantation loss and resorptions after subcutaneous administration at exposures greater than those used clinically. Therefore, the US FDA has not assigned a pregnancy category to this drug, and it is recommended to discuss the risks and benefits with your healthcare provider before using Winlevi during pregnancy.

It is crucial to consult your healthcare provider and carefully consider the potential risks and benefits before using Winlevi cream during pregnancy. The absence of data on the developmental risks associated with its use during human pregnancy highlights the uncertainty about its safety profile in this context. The animal studies indicating the possibility of fetal harm further emphasize the need for caution and medical advice.

Additionally, it is unknown if Winlevi cream passes into breast milk. Therefore, if you are breastfeeding or planning to breastfeed, it is essential to discuss this with your healthcare provider to determine the best way to feed your baby during treatment. The potential risks and benefits of using Winlevi while breastfeeding should be carefully weighed, considering the lack of data on its effects on the breastfed infant and milk production.

Discuss the risks with your healthcare provider

Winlevi is a prescription medication for acne vulgaris treatment. It is not known if Winlevi cream is safe for use during pregnancy. According to WebMD, during pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Winlevi is a topical cream used to treat acne in people 12 years or older. It is a newer medication approved by the FDA in 2020. It is an androgen receptor inhibitor. While the exact mechanism is unknown, it is believed to treat acne by lowering the amount of oil produced by the skin. The active ingredient in Winlevi, clascoterone, is also known as cortexolone 17α-propionate.

Animal reproduction studies have revealed evidence of increased malformations and post-implantation loss and resorptions after subcutaneous administration at exposures greater than those used clinically. However, there are no controlled data in human pregnancy. Therefore, it is important to discuss the potential risks and benefits with your healthcare provider if you are pregnant or planning to become pregnant.

Additionally, Winlevi can cause some serious side effects, including local skin reactions such as itching, burning, skin redness, or peeling. It can also lead to adrenal insufficiency, which may cause symptoms such as nausea, vomiting, loss of appetite, unusual weakness or fatigue, and dizziness. These side effects may be more likely if you have risk factors such as a history of skin reactions, sensitive skin, or using other skin products that can irritate or dry your skin. Be sure to inform your healthcare provider about any medical conditions you have and all the medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

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